A Momenta Pharmaceuticals’ press release Friday revealed a facility run by Pfizer, one its contract manufacturing organisation (CMOs), has received a warning letter from the US Food and Drug Administration (FDA).
The site does the fill/finish for Glatopa – the first generic version of Teva’s bestselling multiple sclerosis drug Copaxone (glatiramer acetate injection) – which Momenta has co-developed with Sandoz.
Duncan Cantor, a spokesman from the Novartis subsidiary, revealed to us the letter was sent to the McPherson, Kansas facility, part of Pfizer’s third-party manufacturing business CentreOne.
“Glatopa 20mg, the first and – to date – only generic version of Copaxone 20mg, has been marketed in the US since June 2015, and we continue to supply the market. The FDA has confirmed to Pfizer that the Warning Letter does not restrict the production or shipment of Glatopa 20 mg.”
However, a 40mg Abbreviated New Drug Application (ANDA) of Glatopa is under regulatory review, and according to Sandoz’s partner Momenta “an approval of the application is dependent on the satisfactory resolution of the compliance observations at the Pfizer facility used to make the final product,” making an approval in the first quarter of 2017 unlikely.
Details of the problems at the site were not divulged, and Pfizer CentreOne did not respond to this publication at the time of publishing.
The McPherson site was one of a number Pfizer added to its network when it acquired Hospira for $17bn in 2015.
It is also one of several Hospira sites which have struggled with compliance issues over the past few years, receiving FDA Form 483s following inspections in the third quarter 2013, October 2012 and November 2011.
And according to the FDA’s Inspection Classification Database, an inspection in April 2015 left the site under the Voluntary Action Indicated (VAI) classification for drug quality assurance.
The site, which has been operational since 1977, was subject to a $150m investment from previous owner Hospira in 2014 to expand capacity, and add automated visual inspection systems.